DEA ISSUES AND THE

IMPACT ON EMS NASEMSO Annual Meeting

September 27, 2012

Carol A. Cunningham, M.D., FACEP, FAAEM

Chair, NASEMSO Medical Directors Council

THE NETWORK

Drug Enforcement Agency (DEA)

Food and Drug Administration (FDA)

Pharmaceutical Manufacturers

Hospitals

Pharmacies

EMS (Providers and Medical Directors)

Patients

ORGANIZATIONAL MISSION

FDA DEA U.S. Department of Health and

Human Services

Public health/patient safety

Scheduled and non-scheduled

medications included along with

food, blood, medical and

radiation-emitting devices,

vaccines, cosmetics, tobacco and

veterinary products

U.S. Department of Justice

Law enforcement/diversion control

systems/drug trade and trafficking

Scheduled medications, legal and

illegal narcotics

FDA PENALTIES

Cessation of manufacturing of medication

Restriction in manufacturing or administration of medication

Seize, arrest, and prosecute for the possession and sale of non-FDA approved substances

Advisory role, rather than a primary role, during admonishment, citation, or litigation against physicians

DEA PENALTIES

Restriction of scheduled medication

categories issued on a DEA narcotics

registration

Issuance of fines

Citation of a DEA narcotic registration

Revocation of a DEA narcotic registration

DEA PENALTIES

DEA WORKGROUP Sabina Braithwaite, MD, MPH

Chair, EMS Committee, ACEP

Carol Cunningham, MD

Chair, Medical Directors Council, NASEMSO

Jim Cusick, MD

Chair, EMS Section, ACEP

Brent Myers, MD, MPH

Member-at Large, Board of Directors, NAEMSP

Allen Yee, MD

EMS Committee, AAEM

DEA MULTI-ORGANIZATIONAL

TASK FORCE ACEP

-Dr. Sabina Braithwaite

-Dr. Joseph Holley

-Dr. Jeffrey Goodloe

-Dr. Craig Manifold

AAEM

-Dr. Allen Yee

NAEMSP

-Dr. J. Brent Myers

NASEMSO

-Dr. Carol Cunningham

-Dr. Joe Nelson

PINNACLE EVENTS October 31, 2011: Presidential Executive Order to the U.S.

Department of Health and Human Services, the FDA, and to

pharmaceutical manufacturers

March 13, 2012: FICEMS TWG to move the DEA Medical Director

Workgroup’s proposal to FICEMS

April 5, 2012: ACCT/ACEP letter to House of Representatives

April 6, 2012: International Association of EMS Chief and EMS Labor

Alliance letter to President Obama

April 16, 2012: ASPR Workshop on Drug Shortages and EMS

July 13, 2012: ASTHO Emergency Care Drug Shortage National

Workgroup

UNRESOLVED HURDLES Off-line medical direction and administration of scheduled

medications

DEA narcotic registrations of EMS agencies, hospitals, and physicians

Utilization/distribution of scheduled medications from the Strategic

National Stockpile assets

EMS medical director risk

- Provision of medical direction/protocols

- Diversion prevention, detection, and reporting

Patient risk secondary to lack of availability and/or administration of

scheduled medications

SHORT-TERM SOLUTIONS

Provision of detailed information regarding current DEA

regulations and procedures to all EMS colleagues

Encourage EMS medical directors to create “just in time”

prehospital protocols for alternative scheduled (and non-

scheduled) medications if legislatively permitted

Enhance networking with hospitals, pharmacies, and other EMS

partners to explore viable options

Initiate a formal relationship/liaison with the DEA agents

assigned to the local and state jurisdictions

UNTAPPED OPPORTUNITIES

Prevention of medication shortage by utilization of any available

avenue

Prioritize the provision of critical lifesaving medications to EMS

agencies

Early notification of medication shortages by pharmaceutical

manufacturers

Waiver of additional fees for federal and state pharmaceutical

licensure amendments that are associated with a medication

shortage

Federal-based cost-effective shelf life extension programs

LONG-TERM SOLUTIONS

Provision of a foundation of knowledge of the critical needs of EMS to all involved parties

Incorporation of EMS-specific administrative and operational factors into future DEA regulations

Establishment of a formal EMS liaison or designated legislative committee position within the DEA

Ongoing relationship of FICEMS with the DEA to ensure coordination to meet the needs of the dynamic and progressive practice and profession of EMS

THE FRIENDSHIP TRAIN

SHAKE A HAND….. MAKE A FRIEND

FDA

Secretary Kathleen Sebelius

Commissioner Margaret Hamburg

DEA

Attorney General Eric Holder, Jr.

Administrator Michele Leonhart